Comparison of ISTp- PYRAMAX-US-RDT to IPTp-SP to Prevent Malaria in Pregnant Women in DRC (ULTRAPYRAPREG)
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
In endemic settings Plasmodium falciparum (Pf) can sequester in the placenta resulting in low
peripheral parasitemia and false negative malaria diagnosis in pregnant women. Intermittent
Preventive Treatment in pregnant women with Sulphadoxine-Pyrimethamine (IPTp-SP) is one of
the World Health Organization's recommended malaria control strategies in sub-Saharan African
countries. The strategy overcomes the risk of misdiagnosis of malaria in pregnant women by
treating them all with SP according to predetermined schedules, but the strategy is now
threatened by the spread of Plasmodium parasite resistant strains. As a necessary
alternative, Intermittent Screening and Treatment in pregnancy (ISTp), aims on the monthly
screening of pregnant women with a malaria rapid diagnostic test (RDT) and the treatment of
positive cases with artemisinin-based combination therapy (ACT) regardless of the presence of
symptoms. The ISTp depends on the performance of the diagnostic tests, and the use of
ultrasensitive RDTs (us-RDTs), which have a higher analytical sensitivity than conventional
RDTs, should improve the efficacy of the strategy.
Unlike IPTp-SP, ISTp prevents overuse of antimalarials and thus limits drug pressure on
malaria parasites. This advantage could be potentiated by using, for pregnant women, an ACT
that is not yet used or should not be used in the field for other strata of the population.
The recently approved new ACT combination, Pyronaridine - Artesunate (Pyramax®) is the ideal
candidate for this purpose.
This study will compare the effects of the ISTp using an us-RDT and Pyramax® (ISTp-US-Py)
with the standard IPTp-SP on maternal malaria indicators (malaria infection, parasite
density), maternal anemia, spontaneous abortions or intrauterine deaths during pregnancy,
fetal morbidity (preterm birth, low birth weight, small for gestational age) and neonatal
mortality at delivery in both study groups through conducting a randomized clinical trial
enrolling second trimester pregnant women in Maternité Esengo Health Center, located in
Kisenso, Kinshasa, the Democratic Republic of the Congo (DRC), a malaria perennial
transmission area.
The results generated from this study will be essential for the National Malaria Control
Program in the selection and implementation of new malaria control policies and addresses the
effectiveness of IPTp-SP decline among pregnant women in the DRC.
Phase:
Phase 3
Details
Lead Sponsor:
University of Kinshasa
Collaborators:
EDCTP European and Developing Countries Clinical Trials Partnership (EDCTP) Novartis
Treatments:
Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine